Director, Quality Operations

Enveda is looking for a Director, Quality Operations to join our team remotely!

The Contribution You Will Make

As Director, Quality Operations you will advance Enveda’s quality capabilities and instill a culture of quality across the company. You will serve as a leader and primary resource for quality and regulatory compliance advice, ensuring that our drug development processes integrate quality from the ground up.

As a member of the Quality team , you will report to the VP, Quality.

You Get To Collaborate On

• Collaborate with cross-functional teams to ensure quality is integrated into all aspects of drug development
• Provide quality and compliance support to all functions ensuring GCP, GLP, and cGMP compliance
• Provide quality oversight for outsourced activities, conduct vendor audits, and establish vendor quality agreements with Enveda’s suppliers
• Develop and implement GXP standardized operating procedures
• Manage audits of Enveda’s clinical trials and other GCP operations
• Provide manufacturing oversight and release GMP investigational products for use
• Conduct phase inspections and provide quality oversight for GLP non-clinical studies
• Manage the document control, training, CAPA, investigation, audit, and change control internal quality systems
• Administer Enveda’s electronic quality management system, records repository, and other quality owned computerized systems
• Provide quality oversight for Enveda’s GXP computerized systems and conduct computer system validation activities
• Provide training on regulatory requirements
• Monitor quality metrics and drive continuous improvement initiatives
  
  

Who will thrive in this role?

• Bachelor’s degree in life sciences, pharmaceutical sciences, or a related field
• In-depth knowledge of GCP, GMP, and GLP regulations and ICH guidelines
• Strong analytical and problem-solving skills
• Excellent communication and leadership abilities.
• If you don't meet all of the requirements listed here, we still encourage you to apply. No job description is perfect, and we might find an even more suitable opportunity that matches your experience.
  
  

What To Expect In The Interview Process

• HR Screen (30 minutes)
• Hiring Manager Interview (45 minutes)
• Work Sample Interview (45 minutes)
• Technical Interview (45 minutes)
• Enveda Culture Interview (30 minutes)
  
  

Some of the total rewards of working here

• Culture: Enveda lives for people
• Salary: $190,000 - $220,000
• Equity
• Healthcare: Medical, dental and vision insurance. Company pays 90% of the premium for employee and dependents.
• 401k: Traditional or Roth 401k matching of 4% (100% of your contributions up to 4% of your annual compensation).
• PTO: Flexible paid time off (that we encourage and celebrate). Company-wide weeklong break to recharge. 10 observed holidays.
• Work-Life Harmony
• Adoption Assistance: At Enveda we want to celebrate and support employees who want to adopt children. We're excited to offer adoption assistance to employees who have completed the adoption process, including placement.
  
  

Come join us!

Our employees are the lifeblood of our work and our inspiration to press on. Together we've built a special place here—a drug discovery platform that's unique in the world with an incredible team collaborating in a creative, transformative culture. Our mission is to bring hope to patients everywhere. Our progress towards that goal would not be possible without talented people like you.

Employee Promise

Using our imagination and dedication, we are working to improve human health and give hope to patients everywhere. Our work together is empowering, trustable and collaborative, enabling you to do your best work.

Enveda's values

Curiosity: Learn and challenge.

Agency: Own and initiate.

Journey: Love the process.

Charity: Take care of each other.

Unity: We are one Enveda.

We value your uniqueness

One of life's gifts is to interact with a variety of people. Each of us has a unique story that shapes how we view the world, and solve problems. Learning from each other enhances our collective wisdom while achieving better outcomes at a faster clip. People from all kinds of backgrounds can succeed in all kinds of roles.

Our work environment appreciates the contributions of every person. Working together is how we produce results that illuminate our Purpose - To Deliver Hope To Every Patient. Unity is a company value because success depends on trusting, working relationships that respect the commonality and differences of people.

At Enveda we are building a place where every person can do the best work of their lifetime.

Enveda is an equal opportunity employer. We do not discriminate on the basis of characteristics protected by federal, state or local laws.

• Please note jobs may be taken down from our website, this does not mean they have been filled. This is to maintain our candidate experience for current applicants. If you are in the interview process and would like to request a copy of the job description, reach out to your recruiting contact.